NCT02285790

Brief Summary

The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

November 1, 2014

Last Update Submit

April 12, 2016

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (1)

  • Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report.

    Assessment will be performed by an experienced board certified pathologist. The number of incomplete excisions will be compared between study- and control group.

    Within the first week after surgical excision of suspected BCC lesion

Secondary Outcomes (2)

  • Comparison of the diagnostic accuracy (sensitivity and specificity) between RCM and punch biopsy in both diagnosing and subtyping BCCs

    Within the first week after surgical excision of suspected BCC lesion

  • Comparison of patient satisfaction between study group and standard of care (control) group by using a standardized web-based questionnaire for patient reported outcome in the management of skin diseases (www.huidvragen.info)

    As assessed at the post-operative visit 3 months after surgical excision

Other Outcomes (1)

  • Comparison of throughput time, defined by the time between arrival at consultation until end of surgical treatment at our outpatient clinic, between study group and standard of care (control) group.

    As assessed at the post-operative visit 3 months after surgical excision

Study Arms (2)

RCM-OSS procedure

EXPERIMENTAL

The Vivascope 1500 will be used (CE certified, Lucid Technologies, Henrietta, NY, USA). Reflectance confocal microscopy (RCM) imaging will be performed for intended use only and interpreted on the Vivascope workstation by two investigators independently at both study locations. The investigators will be blinded to the results of the reference standard. After RCM imaging subjects will receive OSS surgical excision according to subtype. Clinically suspected primary BCCs that are not confirmed by RCM will also receive surgical treatment with a margin of 3mm.

Device: Reflectance confocal microscopyProcedure: Surgical excision

Standard of care procedure

ACTIVE COMPARATOR

Clinical suspected primary BCCs, of all subtypes, will be diagnosed by conventional 3mm punch biopsy of the most elevated part of the lesion. Punch biopsies will be performed under local anesthetics using 1% xylocaine/adrenaline. HE stained sections of the punch biopsies will be evaluated by an experienced board certified pathologist. Subjects will receive surgical excision according to subtype within 6 weeks after punch biopsy has been performed. Clinically suspected new primary BCCs that are not confirmed by punch biopsy will also receive surgical treatment with a margin of 3mm.

Procedure: Punch biopsyProcedure: Surgical excision

Interventions

Reflectance confocal microscopyDEVICE
Also known as: Confocal microscopy, Vivascope 1500
RCM-OSS procedure
Punch biopsyPROCEDURE
Also known as: Biopsy
Standard of care procedure
Surgical excisionPROCEDURE

Excision of the suspected basal cell carcinoma lesion under local anesthetics

Also known as: Surgical removal, Surgery
RCM-OSS procedureStandard of care procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinically suspected new primary BCC as assessed by an experienced board certified dermatologist
  • Patients seen at the outpatient clinic before 12h00 AM will be eligible to participate
  • Patient is willing and able to give written informed consent
  • BCC lesion is suitable for conventional surgical excision under local anesthetics
  • BCC lesion is present since at least 1 month

You may not qualify if:

  • BCC lesion in a high-risk location of the face (H-zone and ears)
  • Contra-indication for conventional surgical excision (primary surgical closure seems not achievable)
  • Recurrent BCC lesion (BCC that has been previously unsuccessfully treated) Macroscopic ulcerating BCC lesions (not feasible for RCM analysis due to technical reasons)
  • Patients with basal cell nevus syndrome
  • Patients treated with hedgehog inhibitor medication
  • Patients with a history of hypersensitivity to and/ or a history of allergy to local anesthesia
  • Unavailability within the following 6 weeks (for example due to holiday or sports)
  • Patients not competent to understand the procedures involved

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dutch Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Location

Academic_Medical_Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (7)

  • Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x.

    PMID: 22251204BACKGROUND

  • Sauermann K, Gambichler T, Wilmert M, Rotterdam S, Stucker M, Altmeyer P, Hoffmann K. Investigation of basal cell carcinoma [correction of carcionoma] by confocal laser scanning microscopy in vivo. Skin Res Technol. 2002 Aug;8(3):141-7. doi: 10.1034/j.1600-0846.2002.20345.x.

    PMID: 12236882BACKGROUND

  • Gonzalez S, Tannous Z. Real-time, in vivo confocal reflectance microscopy of basal cell carcinoma. J Am Acad Dermatol. 2002 Dec;47(6):869-74. doi: 10.1067/mjd.2002.124690.

    PMID: 12451371BACKGROUND

  • van der Geer S, Reijers HA, van Tuijl HF, de Vries H, Krekels GA. Need for a new skin cancer management strategy. Arch Dermatol. 2010 Mar;146(3):332-6. doi: 10.1001/archdermatol.2010.1.

    PMID: 20231509BACKGROUND

  • van der Geer S, Frunt M, Romero HL, Dellaert NP, Jansen-Vullers MH, Demeyere TB, Neumann HA, Krekels GA. One-stop-shop treatment for basal cell carcinoma, part of a new disease management strategy. J Eur Acad Dermatol Venereol. 2012 Sep;26(9):1154-7. doi: 10.1111/j.1468-3083.2011.04184.x. Epub 2011 Jul 19.

    PMID: 21771105BACKGROUND

  • van Cranenburgh OD, de Korte J, Sprangers MA, de Rie MA, Smets EM. Satisfaction with treatment among patients with psoriasis: a web-based survey study. Br J Dermatol. 2013 Aug;169(2):398-405. doi: 10.1111/bjd.12372.

    PMID: 23565643BACKGROUND

  • Kadouch DJ, Wolkerstorfer A, Elshot Y, Zupan-Kajcovski B, Crijns MB, Starink MV, Bekkenk MW, van der Wal AC, Spuls PI, de Rie MA. Treatment of Basal Cell Carcinoma Using a One-Stop-Shop With Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial. JMIR Res Protoc. 2015 Sep 10;4(3):e109. doi: 10.2196/resprot.4303.

    PMID: 26362616DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Microscopy, ConfocalBiopsySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

MicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCytodiagnosisCytological TechniquesClinical Laboratory TechniquesSpecimen HandlingDiagnostic Techniques, Surgical

Study Officials

  • Menno A. de Rie, MD, PhD

    Head of Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. M.A. de Rie

Study Record Dates

First Submitted

November 1, 2014

First Posted

November 7, 2014

Study Start

January 1, 2015

Primary Completion

October 1, 2015

Study Completion

April 1, 2016

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

NL(2)